In Depomed Inc. v. Actavis Elizabeth LLC, et al., the District of New Jersey blocked Actavis from producing and selling generic gabapentin once-daily tablets. Actavis filed an ANDA for approval to market a generic version of Depomed’s timed release Gralise®, a once-a-day gabapentin treatment for post-herpetic neuralgia (PHN), or nerve pain due to shingles. Following a bench trial in May, the Court found that Actavis’s generic product infringes claims in seven patents covering Gralise® directed to an extended-release gabapentin oral dosage form that releases gabapentin in the stomach over several hours. The patents expire between September 2016 and February 2024. The ruling further held that Actavis failed to make a showing of invalidity as to any of the patents-in-suit.
The Court also found that Actavis contributed to the infringement of method of treatment claims of four asserted patents. Physicians and patients will directly infringe the asserted method claims by administering the drug according to the label’s method of treating. Actavis knew of Depomed’s patents covering Gralise® based on its Paragraph IV certification regarding those patents. There are not significant non-infringing uses for the ANDA product because it may not be marketed for non-infringing uses. On the last point, the Court reasoned: “Drug companies are not permitted to promote their products for anything other than what is approved in the label. . . . . Defendant argues that this element of the contributory infringement analysis (i.e., that there are not significant noninfringing uses) has not been met due [to] the existence of a number of off-label uses  for the ANDA. However, because Actavis cannot expressly market its product for any of these uses, the court finds this third element to be met.”
This reasoning illustrates a subtle rule that has emerged in ANDA cases. In Eli Lilly & Co. v. Actavis Elizabeth LLC (Fed. Cir. 2011), defendants sold an ANDA product labeled solely for the patented use, but they argued that there were off-label uses of the drug. As to contributory infringement, the Federal Circuit reversed the district court’s holding that liability was avoided “if the product has any ‘frequent’ non-infringing use,” reasoning that “defendants are restricted from selling a federally regulated drug for unapproved uses,” and the fact that physicians may nonetheless prescribe it for unauthorized use does not avoid infringement by a product that is authorized to be sold solely for the infringing use. Thus, where a product label indicates that a generic may be used only for an approved use, and such use infringes a patentee’s method claims, it appears to be irrelevant whether off-label uses of the product exist.
Following its victory in the District of New Jersey, on September 5, Depomed won a summary judgment motion in the District of D.C. seeking an order requiring the FDA to grant Gralise® orphan drug status for the treatment of PHN. An “orphan drug” is one that treats a rare disease affecting fewer than 200,000 Americans. This designation provides Depomed the exclusive right to market a drug for the treatment of PHN for the next seven years. Together, the two rulings will provide Depomed with nearly a decade of market exclusivity for Gralise®.